Participant flow

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia · Source last updated 2018-12-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   CONDITIONING REGIMEN: Patients receive busulfan IV QD, every 12 hours, or every 6 hours over 2-3 hours on days -8 to -5, cyclophosphamide IV QD over 60 minutes on days -4 and -3, and melphalan IV over 15-30 minutes on day -1. TRANSPLANT: Patients undergo allogeneic HCT no sooner than 24 hours after the last dose of chemotherapy. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO

   id

   FG000

   title

   Arm I (Busulfan, Cyclophosphamide, Melphalan)

2. description

   CONDITIONING REGIMEN: Patients receive busulfan as in Arm I and fludarabine phosphate IV over 1 hour on days -5 to -2. TRANSPLANT: Patients undergo allogeneic HCT as in Arm I. Patients receive tacrolimus IV or PO on days -1 to 98 (related donor) or 180 (unrelated donor) and mycophenolate mofetil IV over 2 hours or PO every 8 hours on days 1-30 (related donor) or 45 (unrelated donor). Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic HCT Busulfan: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Pharmacological Study: Correlative studies Tacrolimus: Given IV or PO

   id

   FG001

   title

   Arm II (Busulfan, Fludarabine Phosphate)

3. description

   Patients who were not randomized and did not proceed to transplant because they did not meet all the protocol requirement for randomization

   id

   FG002

   title

   ARM III (Non-Randomized)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      type

      Ineligible

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         10

      type

      No Transplant Planned

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         15

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         15

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice